UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for UNKNOWN manufactured by William Cook Europe.

Event Text Entries

[187557925] It is alleged that "[pt] received a cook celect filter on (b)(6) 2012. It is alleged that the [pt] was injured without further explanation. Hospital and medical records have been requested but not yet provided. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005580113-2020-00312
MDR Report Key9890309
Date Received2020-03-27
Date of Report2020-03-27
Date Facility Aware2020-03-11
Report Date2020-03-27
Date Reported to FDA2020-03-27
Date Reported to Mfgr2020-03-11
Date Added to Maude2020-03-27
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN
Generic NameDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Product CodeDTK
Date Received2020-03-27
Catalog NumberUNKNOWN
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerWILLIAM COOK EUROPE
Manufacturer AddressSANDET 6 BJAEVERSKOV 4632 DA 4632


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening 2020-03-27

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